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Claims for Patent: 4,620,974

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Claims for Patent: 4,620,974

Title: Pharmaceutical composition containing a liquid lubricant
Abstract:Pharmaceutical compositions produced with liquid, hydrophilic lubricants possessing markedly improved dissolution rates.
Inventor(s): Hersh; Marvin (Strafford, PA), Lentine; Charles W. (Brookhaven, PA)
Assignee: American Home Products Corporation (New York, NY)
Application Number:06/730,232
Patent Claims: 1. A hard gelatin, telescoping two-piece cap and body capsule filled with a solid pharmaceutical composition free of solid hydrophobic lubricant comprising a dry, powdery, dust-producing therapeutic agent in intimate admixture with a non-solubilizing amount of a pharmaceutically acceptable, liquid, hydrophilic, dust-reducing, lubricant, said lubricant being a polyethylene glycol of molecular weight from about 200 to about 900, present in said admixture in from about 0.5 to about 25 weight percent of composition.

2. A filled hard gelatin capsule of claim 1 in which said lubricant is a polyethylene glycol which possesses a molecular weight of about 380 to about 420.

3. A filled hard gelatin capsule of claim 1 in which said admixture contains a pharmaceutically acceptable surface active agent.

4. A filled hard gelatin capsule of claim 1 in which said surface active agent is a fatty ester of polyoxyethylene sorbitan, a polyoxyethylene condensate of a hydrophobic base formed by polymerization of propylene oxide and propylene glycol, sorbitan monolaurate, octylphenoxypolyethoxy ethanol, cetylpyridinium chloride or dioctyl sodium sulfosuccinate.

5. A filled hard gelatin capsule of claim 1 in which said therapeutic agent is oxazepam.

6. A filled hard gelatin capsule of claim 1 in which said solid pharmaceutical composition comprises from about 10 to about 30 milligrams oxazepam, about 0.5 to about 25 weight percent of composition of liquid polyethylene glycol of molecular weight from about 200 to about 900, about 0.1 to about 25 weight percent of composition of surfactant, plus a filler.

7. A filled hard gelatin capsule of claim 1 in which said solid pharmaceutical composition comprises from about 10 to about 30 milligrams oxazepam, about 3 to about 11 weight percent ratio to active of polyethylene glycol lubricant of molecular weight from about 380 to 420, about 0.5 to about 2.5 weight percent ratio to active of nonionic surfactant, and a filler.

8. A filled hard gelatin capsule of claim 7 in which said solid pharmaceutical composition comprises about 10 milligrams oxazepam, about 167 milligrams lactose, about 6.6 milligrams croscarmellose sodium, about 1.1 milligram polyethylene glycol of molecular weight from about 380 to about 420 and about 0.22 milligrams of a fatty ester of polyoxyethylene sorbitan surfactant.

9. A filled hard gelatin capsule of claim 7 in which said solid pharmaceutical composition comprises about 15 milligrams oxazepam, about 162 milligrams lactose, about 6.6 milligrams croscarmellose sodium, about 1.1 milligram polyethylene glycol of molecular weight from about 380 to about 420 and about 0.22 milligrams of a fatty ester of polyoxyethylene sorbitan surfactant.

10. A filled hard gelatin capsule of claim 7 in which said solid pharmaceutical composition comprises about 30 milligrams oxazepam, about 147 milligrams lactose, about 6.6 milligrams croscarmellose sodium, about 1.1 milligram polyethylene glycol of molecular weight from about 380 to about 420 and about 0.22 milligrams of a fatty ester of polyoxyethylene sorbitan surfactant.
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